Quality/GMPs

The drug is formulated to improve cardiac contractility with a reduced effect on heart rate, blood pressure, and myocardial oxygen consumption while potentially avoiding adverse events associated with current inotrope therapies.

Top of CDER’s to-do list for 2020 is tracking adverse events more effectively and combating the opioid crisis.

The approval comes after the results of a clinical trial that showed 61% of patients had a response lasting six months or longer.

The approval was based on successful data from a years-long trial that assessed patient’s tumor status every 12 or 24 weeks for up to 24 months.

The company has various projects and launches scheduled for 2020 as part of its anniversary celebration.

The numbers of new molecular entities approved in 2019 are close to or exceed FDA’s performance in most previous years.

The agency sent a warning letter to Henan Kangdi Medical Devices Co. Ltd after an inspection found CGMP violations that included a variety of failures of the company’s quality unit.

While falling short of the 2018 record levels, US drug approval numbers continue to set the pace globally.

FDA sent a warning letter to GPT Pharmaceuticals Pvt. Ltd. after inspectors found CGMP violations that included equipment that was not properly maintained.

Pressures on FDA will affect industry’s success in bringing new therapies to market.

Focusing on symptoms instead of root causes locks teams into a corrective, rather than preventive, mindset.

FDA sent a warning letter to Dercher Enterprises, Inc., DBA Gordon Laboratories, for CGMP violations and adulterated drug products.

The guidance describes procedures for obtaining an additional National Drug Code for prescription drugs imported into the United States.

The European Medicines Agency and its European partners have launched a pilot program for cooperation in the inspection of facilities that manufacture sterile drug products.

The revision process and the resulting publication of proposed and official updates for pharmacopoeias around the world are described.

This article describes the revision process and the resulting publication of proposed and official updates for pharmacopoeias around the world.

An effective surveillance program for monitoring the activities of pharmacopoeias around the world requires processes, people, and tools from across a company.

An effective surveillance program for monitoring the activities of pharmacopoeias around the world requires processes, people, and tools from across a company.

An understanding of global and national pharmacopoeias is crucial to understanding change processes and access to different markets.

The process used to monitor and participate in pharmacopoeial changes is described.

Warning letters tell the tale of missteps by drug companies and offer a path to compliance for quality teams that monitor these enforcement actions.

Production and process controls, organization and personnel were the top problems found, while packaging and labeling citations increased in 2017 and 2018.

Find links to pertinent regulatory and standard setting resources, guidance documents, and guidelines.

Connect with pharmaceutical and healthcare regulatory authorities around the world via this directory.

Quality risk management plans provide identified actions to ensure a continuous supply of safe and effective drug products

According to a consent decree of permanent injunction issued in September 2019, the health and wellness companies must recall and stop distributing products until the companies comply with the Federal Food, Drug, and Cosmetic Act and other requirements included in the consent decree.

While labor and tariff reforms in the revised North American trade agreement may have more visible impacts on the United States economy, the final document levels a major blow to exclusivity and patent protections important to innovator biotech and pharma companies.

FDA has an official new leader, following a Senate vote to confirm Stephen Hahn as the agency’s next commissioner.

The biologic is a novel bone builder that has a dual effect of increasing bone formation and reducing bone loss.

FDA’s Office of New Drugs restricting aims to improve scientific exchange and information sharing among review professionals.